一项评价青少年和青年癌症幸存者荒野项目的混合方法随机对照试验研究方案：WAYA 研究。
Protocol of a mixed-method randomised controlled pilot study evaluating a wilderness programme for adolescent and young adult cancer survivors: the WAYA study.
机构信息
National Research Center in Complementary and Alternative Medicine (NAFKAM), Department of Community Medicine, Faculty of Health Sciences, UiT the Arctic University of Norway, Tromsø, Norway
Department of Health Sciences, Mid Sweden University, Sundsvall, Sweden.
出版信息
BMJ Open. 2022 May 9;12(5):e061502. doi: 10.1136/bmjopen-2022-061502.
INTRODUCTION
The majority of childhood, adolescent and young adult (AYA) cancer survivors suffer from long-term and late effects such as fatigue, psychological distress or comorbid diseases. Effective health promotion strategies are needed to support the health of this vulnerable group. This protocol provides a methodological description of a study that aims to examine the feasibility and safety of performing a randomised clinical trial (RCT) on a wilderness programme that is developed to support the health of AYA cancer survivors.
METHODS AND ANALYSIS
The pilot RCT study has a mixed-method design, including quantitative and qualitative evaluations. Participants are AYAs, aged 16-39 years, that have been diagnosed with cancer during childhood, adolescence or young adulthood. A total of 40 participants will be randomly assigned to a wilderness programme (n=20) or a holiday programme (n=20). Both arms include participation in an 8-day summer programme, followed by a 4-day programme 3 months later. Primary outcomes are feasibility and safety parameters such as time to recruitment, willingness to be randomised, programme adherence and adverse effects. Secondary outcomes include self-reported health such as self-esteem, quality of life, self-efficacy and lived experiences. Descriptive statistics will be used to analyse outcomes and explore indications of differences between the programmes. Interviews are analysed by directed content analysis and hermeneutic phenomenology. A convergent parallel mixed-method analysis design will be applied to integrate quantitative and qualitative data. Results of this feasibility study will inform the preparation for a larger RCT with AYA cancer survivors.
ETHICS AND DISSEMINATION
The study protocol is approved by the Swedish Ethical Review Authority (reference: 2020-00239). This study will be performed between January 2021 and December 2023. Results will be published in international peer-reviewed journals, presented at conferences and disseminated to participants, cancer societies, healthcare professionals and outdoor instructors.
TRIAL REGISTRATION NUMBER
NCT04761042.
简介
大多数儿童、青少年和青年癌症幸存者（AYA）都患有长期和晚期影响，如疲劳、心理困扰或合并症。需要有效的健康促进策略来支持这一弱势群体的健康。本方案提供了一项研究的方法描述，该研究旨在检验一项针对荒野计划的随机临床试验（RCT）的可行性和安全性，该计划旨在支持 AYA 癌症幸存者的健康。
方法和分析
该试点 RCT 研究采用混合方法设计，包括定量和定性评估。参与者为年龄在 16-39 岁之间的 AYA，他们在儿童期、青少年期或青年期被诊断患有癌症。总共将有 40 名参与者被随机分配到荒野计划（n=20）或度假计划（n=20）。两个组都将参加为期 8 天的夏季计划，然后在 3 个月后参加为期 4 天的计划。主要结局是可行性和安全性参数，如招募时间、随机意愿、计划依从性和不良影响。次要结局包括自我报告的健康状况，如自尊、生活质量、自我效能感和生活经历。将使用描述性统计来分析结果并探索两个计划之间的差异迹象。访谈将通过定向内容分析和解释学现象学进行分析。将应用收敛并行混合方法分析设计来整合定量和定性数据。这项可行性研究的结果将为与 AYA 癌症幸存者进行更大规模的 RCT 做准备。
伦理和传播
该研究方案已获得瑞典伦理审查局的批准（参考号：2020-00239）。本研究将于 2021 年 1 月至 2023 年 12 月进行。结果将发表在国际同行评议期刊上，在会议上展示，并分发给参与者、癌症协会、医疗保健专业人员和户外指导员。
试验注册编号
NCT04761042。
Zotero 插件